UnknownNot Applicable

Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases

France340 participantsStarted 2021-01-27

Plain-language summary

The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presenting with colorectal liver metastases requiring liver resection ± concomitant radiofrequency ablation. * Qualifying for both a laparoscopic approach and an open approach. * Informed written consent. * Affiliated to health insurance regimen. Exclusion Criteria: * Hybrid liver resection (including both laparoscopic and open resection). * Liver resection requiring an associated vascular or biliary reconstruction. * Contraindication to surgery. * Contraindication to laparoscopy (pneumoperitoneum). * ASA (American Society of Anesthesiologists) score IV or V or life expectancy \< 3 months. * Poor comprehension of French language or cognitive impairment * Pregnancy or breastfeeding. * Patient under guardianship or unable to give consent * People particularly protected by French law.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of overall complications using the comprehensive complication Index (CCI)

Timeframe: Within 90 days postoperatively or at any time during hospitalization.

Trial details

NCT IDNCT04163887

SponsorInstitut Mutualiste Montsouris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-27

Contact for this trial

Caroline RIX

+33 156616371 caroline.rix@imm.fr

View on ClinicalTrials.gov More Liver Metastasis Colon Cancer trials